UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019492
Receipt number R000022539
Scientific Title survey of changes in food preference by pregnancy
Date of disclosure of the study information 2015/10/26
Last modified on 2018/05/04 20:47:56

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Basic information

Public title

survey of changes in food preference by pregnancy

Acronym

survey of changes in food preference by pregnancy

Scientific Title

survey of changes in food preference by pregnancy

Scientific Title:Acronym

survey of changes in food preference by pregnancy

Region

Japan


Condition

Condition

pregnancy

Classification by specialty

Obstetrics and Gynecology Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to clarify whether food preference of the woman changes by pregnancy.

Basic objectives2

Others

Basic objectives -Others

Factors concerned with change of food preference.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Primary outcome is to investigate the ratio of woman who changes food preference by pregnancy.

Key secondary outcomes

Factors concerned with change of food preference. Age, the first pregnancy or not, partner's food preference and so on.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

45 years-old >=

Gender

Female

Key inclusion criteria

A woman after the delivery

Key exclusion criteria

no exclusion criteria

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayuki Miwa

Organization

National Hospital Organization Saitama National Hospital

Division name

department of Pediatrics

Zip code


Address

Suwa 2-1, Wako, Saitama pref., Japan

TEL

048-462-1101

Email

m38miwa@z2.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masayuki Miwa

Organization

National Hospital Organization Saitama National Hospital

Division name

department of Pediatrics

Zip code


Address

Suwa 2-1, Wako, Saitama pref., Japan

TEL

048-462-1101

Homepage URL


Email

m38miwa@z2.keio.jp


Sponsor or person

Institute

Department of Pediatrics, Saitama National Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Pediatrics, Saitama National Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

国立病院機構埼玉病院(埼玉県)


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 26 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 10 Month 09 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 26 Day

Last follow-up date

2016 Year 06 Month 30 Day

Date of closure to data entry

2016 Year 07 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is a retrospective cohort study to investigate whether a change of food preferencw occurred to the woman who became pregnant.
We perform a questionnaire to puerperae, who gave birth in Saitama National Hospitl, at the time of one month age medical examination of baby.


Management information

Registered date

2015 Year 10 Month 25 Day

Last modified on

2018 Year 05 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022539


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name